NCT02835261

Impact of Sleep Restriction in Women

Completed NA Last updated 14 October 2025

What this trial tests

NA trial testing Sleep Restriction in Sleep in 54 participants. Completed in 25 February 2021.

Timeline

1 September 2016

Primary endpoint
25 February 2021

25 February 2021

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	54
Start date	1 September 2016
Primary completion	25 February 2021
Estimated completion	25 February 2021
Sites	1 location across United States

Drugs / interventions tested

• Sleep Restriction

Conditions studied

• Sleep — all drugs for Sleep →
• Cardiovascular Disease — all drugs for Cardiovascular Disease →
• Obesity — all drugs for Obesity →

Sponsor

Columbia University

Who can join

Adults 20 to 75, female only, with Sleep or Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overall goal of this project is to test the hypothesis that long-term, sustained sleep restriction (SR), in women, will lead to increased cardio-metabolic risk. This will be characterized by increases in visceral adiposity, unhealthy lifestyle behaviors (poor dietary quality and low physical activity) and cardio-metabolic risk factors (blood pressure, glucose intolerance) relative to habitual sleep (HS). The investigators expect these changes to be worse in pre- compared to post-menopausal women.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of Inadequate Sleep on Blood Pressure and Endothelial Inflammation in Women: Findings From the American Heart Association Go Red for Women Strategically Focused Research Network.
   Aggarwal B, Makarem N, Shah R, Emin M, et al · · 2018 · cited 48× · PMID 29886425 · DOI 10.1161/jaha.118.008590
2. Mild sleep restriction increases endothelial oxidative stress in female persons.
   Shah R, Shah VK, Emin M, Gao S, et al · · 2023 · cited 43× · PMID 37717072 · DOI 10.1038/s41598-023-42758-y
3. The effects of insufficient sleep and adequate sleep on cognitive function in healthy adults.
   Zimmerman ME, Benasi G, Hale C, Yeung LK, et al · · 2024 · cited 38× · PMID 38233280 · DOI 10.1016/j.sleh.2023.11.011
4. Chronic Insufficient Sleep in Women Impairs Insulin Sensitivity Independent of Adiposity Changes: Results of a Randomized Trial.
   Zuraikat FM, Laferrère B, Cheng B, Scaccia SE, et al · · 2024 · cited 30× · PMID 37955852 · DOI 10.2337/dc23-1156
5. Mild sleep restriction increases 24-hour ambulatory blood pressure in premenopausal women with no indication of mediation by psychological effects.
   St-Onge MP, Campbell A, Aggarwal B, Taylor JL, et al · · 2020 · cited 20× · PMID 32135337 · DOI 10.1016/j.ahj.2020.02.006
6. Mediterranean diet components are linked to greater endothelial function and lower inflammation in a pilot study of ethnically diverse women.
   Shah R, Makarem N, Emin M, Liao M, et al · · 2020 · cited 18× · PMID 32045786 · DOI 10.1016/j.nutres.2020.01.004
7. Impact of change in bedtime variability on body composition and inflammation: secondary findings from the Go Red for Women Strategically Focused Research Network.
   St-Onge MP, Campbell A, Zuraikat F, Cheng B, et al · · 2020 · cited 17× · PMID 32132641 · DOI 10.1038/s41366-020-0555-1
8. Actigraphy-Derived Sleep Is Associated with Eating Behavior Characteristics.
   Barragán R, Zuraikat FM, Tam V, Scaccia S, et al · · 2021 · cited 16× · PMID 33807690 · DOI 10.3390/nu13030852